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Life Threatening? No
Write-up: Information has been received from a registered nurse through the Merck pregnancy registry concerning a 17 year old female patient with folliculitis, genital condyloma and no medical history or allergies, who on 07-MAR-2007 was vaccinated IM with a first 0.5ml dose of Gardasil (Lot# 655618/0186U). On 03-MAY-2007 the patient received a second dose of Gardasil (Lot# 657621/0387U). Concomitant therapy included, AUGMENTIN and trichloroacetic acid. The patient stated her last menstrual period was 15-APR-2007. The nurse reported that the patient kept changing the date at each visit. The patient was sent to an OB/GYN and it was determined that she was 4 weeks pregnant as of 21-MAY-2007. Diagnostic laboratory studies performed were an ultrasound on 21-MAY-2007 due to clotting/spotting which resulted as 5 week gestational sac. On 25-MAY-2007 and 30-MAY-2007, HCG quantitative test were performed which resulted as 2231 and 118, respectively. The nurse mentioned that the patient has not experienced any difficulties with the pregnancy as this time. On 27-MAY-2007, it was reported that the patient had a spontaneous abortion. She was 6 weeks from LMP. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
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